Study on Vemurafenib and Cobimetinib for Treating High-Risk Thyroid Cancer with BRAFV600E Mutation
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT06440850
This clinical trial is testing how well the drugs vemurafenib and cobimetinib work in treating patients with high-risk thyroid cancer that has a specific genetic mutation, in preparation for radioactive iodine therapy.
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Program Overview
This study is exploring the effectiveness of two drugs, vemurafenib and cobimetinib, in treating patients with high-risk thyroid cancer that has a BRAFV600E mutation. These drugs are kinase inhibitors, which means they block a protein that tells cancer cells to grow. By doing this, they may help slow down or stop the spread of cancer cells. The study aims to see if this combination works better for patients before they receive radioactive iodine therapy.
Description
The main goal of this study is to see how many patients with high-risk thyroid cancer and a BRAF mutation respond well to treatment with vemurafenib and cobimetinib before they receive radioactive iodine therapy. Researchers will also look at how the treatment affects scans of the cancer, the safety and side effects of the drugs, and how well the treatment helps the radioactive iodine work. They will also study changes in a protein called thyroglobulin and the characteristics of tumors in patients who respond to the treatment compared to those who do not.
Participants will take vemurafenib twice a day and cobimetinib once a day for a set period, followed by a break, and then continue for another period. After this, they will receive radioactive iodine and continue taking the drugs for a few more days. Participants will also receive injections to prepare for diagnostic scans and undergo various imaging tests and blood sample collections throughout the study. After completing the treatment, participants will have follow-up visits every three months for up to a year.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Willing to be followed for about 14 months.
- Adults aged 18 years or older.
- Have thyroid cancer of follicular origin (such as papillary or follicular types).
- Have a known BRAFV600E mutation in the cancer.
- Considered high risk for cancer recurrence based on specific medical criteria.
- Have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Have controlled blood pressure and good kidney function.
- Have adequate blood cell counts and liver function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a year after.
- Non-English speakers and adults who cannot consent themselves are not excluded.
Exclusion Criteria
- Have had prior radioactive iodine treatment.
- Have received previous treatments targeting BRAF or MEK, or other specific cancer drugs.
- Have low to intermediate risk thyroid cancer.
- Have a type of thyroid cancer that is not differentiated or is medullary.
- Have had major surgery within four weeks before starting treatment.
- Have certain medical conditions that affect drug absorption or heart function.
- Have active bleeding or infections.
- Have had another active cancer within the past two years, except for certain skin or cervical cancers.
- Are pregnant or breastfeeding.
- Have had a recent injection of a radio-contrast agent.
- Have a history of certain eye conditions.
- Have known allergies to the study drugs.
- Have any condition that would make it unsafe to participate or affect study results.
- Are unable to comply with study procedures.
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